National Medicare Coverage Determination for Lung Cancer Screening Significantly Expands Eligibility

Last month, the Centers for Medicare and Medicaid Services (CMS) announced its final decision on a National Coverage Determination (NCD)* that expands reimbursement eligibility for low-dose computed tomography (LDCT) lung cancer screening ).

In a review of its 2015 NCD, CMS is lowering the age of eligibility for smokers to begin annual lung cancer screenings using low-dose CT scans from 55 to 50. In addition, CMS increases a person’s last year of eligibility from 77 to 80, and the reduction in smoking history per pack-year from 30 to 20 pack-years.

Lung cancer is one of the most common cancers and the leading cause of cancer-related death in men and women in the United States. This particular screening – LDCT – is aimed at the early detection of non-small cell lung cancer.

In the absence of a national coverage policy, a Medicare Part B item or service, such as a cancer screening, may be covered at the discretion of Medicare administrative contractors and Medicare Advantage plans. But in 2015, CMS took the unusual step of launching an NCD for LDCT, to which all Medicare administrative contractors and Medicare Advantage plans are bound.

By law, Medicare coverage for medical technologies and other health services — including prescription drugs, diagnostics, and devices — is limited to those deemed reasonable and necessary for the diagnosis or treatment of a disease or illness. ‘a wound.

The original NCD was published in February 2015. At the time, based on the reasonable and necessary standard, CMS determined that there was sufficient evidence to cover an annual lung cancer screening with low-level CT scans. dose, as an additional preventive service benefit under the Medicare Part B Program, provided there is lung cancer screening counseling and a shared decision-making visit. For example, Medicare paid for lung cancer screening, counseling, and shared decision-making visits.

For Medicare coverage of lung cancer screening with low-dose CT scans, beneficiaries had to meet all of the following eligibility criteria:

  • 55 to 77 years old;
  • Asymptomatic (no signs or symptoms of lung cancer);
  • A smoking history of at least 30 pack-years (one pack-year means smoking one pack a day for one year; one pack equals 20 cigarettes);
  • Current smoker or person who has quit smoking within the past 15 years;
  • Received a written order from a doctor for screening for lung cancer with low-dose CT scans. These screening orders must be duly documented in the beneficiary’s medical file;
  • Prior to the first screening, the beneficiary should receive counseling and a shared decision-making visit.

Over the past several years, however, several key informants have identified some barriers to the effectiveness of the screening program, as noted in the NCD 2015. They therefore proposed to expand age eligibility and reduce history from 30 to 20 years of smoking, but also to simplify counseling and shared decision-making requirements, as well as reduce demands on radiological imaging facilities.

In 2021, for example, several medical professional societies, including the Society of Thoracic Surgeons, the American College of Radiology, and groups like the Association for Quality Imaging, called on CMS to incorporate more liberal guidelines on the criteria for screening eligibility.

Stakeholder requests to expand CMS coverage of lung screening align with new United States Preventive Services Task Force (USPSTF) standards. The USPSTF is “an independent panel of primary care and prevention experts that systematically reviews evidence of effectiveness and develops recommendations for preventive clinical services,” such as cancer screening.

In addition to age eligibility and changes in smoking history, screening advocates urge:

  • simplification of advice and shared decision-making requirements;
  • removal of eligibility criteria that required X-ray imaging centers to provide smoking cessation interventions for current smokers;
  • removal of the requirement for imaging facilities to participate in a data registry.

In November 2021, CMS published a proposed new DTM on lung cancer screening by LDCT. This revised NCD is in many respects consistent with the requests and comments of testing advocates.

The idea behind removing perceived barriers is to improve recipient access to lung cancer screenings. But, there are those who say it’s a bad idea, as it risks oversimplifying shared decision-making for lung cancer screening. In effect, this removes the requirement that shared decision-making must include an appropriate assessment of the pros and cons of screening.

Theoretically, at least, the push to expand screening to low-risk groups could lead to overdiagnosis and excessive radiation exposure. Accordingly, critics of NCD suggest that LDCT screening should only be offered to heavy smokers, after a balanced presentation of potential benefits and harms. The latter would include a detailed discussion of possible overdiagnosis, but also false positive diagnoses, the potential for an excessive number of diagnostic procedures and the possibility of radiation-induced cancers.

There’s also the broader question of whether Medicare should pay on a regular basis for a proliferating number of other cancer screenings that have been launched in recent years. For example, lawmakers introduced a bill requiring Medicare to pay for expensive liquid biopsy tests that have limited evidence support. Experts aware of the limited clinical utility of these tests have countered by asking whether Medicare should be required to cover annual genomic sequencing of blood for the purpose of “early detection of cancer in many types of cancer.”

However, not all projections are created equal, if you will. A relaxation of eligibility criteria for LDCT screening has empirical support in terms of net benefit to recipients. It is therefore important that CMS analyzes each case of cancer screening separately to determine the potential benefits and harms. Provided safeguards are met around the issue of proper assessment of the possible harms of LDCT screening, expanding Medicare beneficiary reimbursement eligibility for lung cancer screening with LDCT is likely a reasonable change. of politics.

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